Notice on New Window for Dossier Submissions
This is to inform all stakeholders that the window for submission of new product dossiers will open on 29th April 2024. This submission will be on the NAFDAC Dossier Management System (DMS) Version 2. All applicants who intend to submit dossiers during this window should note the following. New applicants will need to create their […]
Sources of API’s and Excipients
QUALITY OF ACTIVE PHARMACEUTICAL INGREDIENTS (APIs) USED IN THE MANUFACTURE OF FINISHED PHARMACEUTICAL PRODUCTS (FPPs) FOR THE NIGERIAN MARKET The quality of Active Pharmaceutical Ingredients (APIs) used in Finished Pharmaceutical Products (FPPs) manufacturing directly impacts the safety, efficacy, quality, regulatory compliance, consistency, supply chain, reputation, and cost-effectiveness of pharmaceutical products. Pharmaceutical companies and manufacturers must […]
Introduction of “Pre-Submission Meetings” for Submission of CTD Dossiers for Locally Manufactured Pharmaceutical Products.
The management of NAFDAC has noticed with dismay the high number of dossier applications that do not meet minimal requirements for submission of CTD dossiers. As part of its continuous improvement efforts and strengthening of its regulatory systems, NAFDAC is introducing a ‘pre-submission meeting’ applicable only to local pharmaceutical manufacturers to enhance the quality of […]
Press Release on the Guardian Online Publication “Nestle Adds Sugar to Infant Milk Sold in Poorer Countries”: NAFDAC’s Response
The attention of the Management of the National Agency for Food and Drug Administration and Control (NAFDAC) has been drawn to The Guardian online publication of 17 April 2024 being circulated widely to the general public via social media stating that “Nestle, the world’s largest consumer goods company, adds sugar and honey to infant milk […]
Directive Inclusion of Bioequivalent Data in Dossiers for Product Registration
Dear Stakeholders and international partners, January 2025 Mandatory Inclusion of Bioequivalence Data in Dossier Submissions for Drug Products that do not Qualify for Biowaivers It has been discussed and made public at different meetings of manufacturers that the inclusion of Bioequivalence data in Dossier submissions will be mandatory from January 2025. Multisource pharmaceutical products (generic […]
Public Alert No. 013/2024 -Alert on Recall of Benylin Paediatrics Syrup in Nigeria
The National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying the public of the recall of one lot of Benylin PaediatricsSyrup manufactured by Johnson & Johnson, following recent toxicity findings in the laboratory on the product. Laboratory analysis conducted on the product showed that it contains an unacceptable high level of Diethylene glycol and […]
Public Alert No. 012/2024 – Alert on the Ban on the Sale of Dex Luxury Bar Soap due to Butyphenyl Methylpropional (BMHCA) content
The National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying the public of the ban on the sale of Dex Luxury Bar Soap (No 6 mystic flower) by the European Union (EU). The product does not comply with the Cosmetic Products Regulation as it is said to contain Butyphenyl Methylpropional (BMHCA) which is prohibited […]
Public Alert No. 011/2024 – Alert on the Sale of Counterfeit Tandak Injection in Nigeria
The National Agency for Food and Drugs Administration and Control (NAFDAC) is informing the public of the sale of counterfeit TANDAK injection 1.5g powder and water for injection, Manufactured by Intracin Pharmaceuticals PVT. LTD C-1, B-53, G.I.D.C Estate, Nadiad- 387001, Gujarat, India. This product was discovered in Gombe state, Nigeria, and reported to the Agency […]
Relocation of Open Drug Marketers to Coordinated Wholesale Centre (CWC) in Kano: Fight Against Substandard and Falsified Medicines (SFS)
The chaotic drug distribution system in Nigeria has been a sore point to drug regulatory Agencies, especially to NAFDAC. This disorderly chain of movement of medicine in the supply chain, from the manufacturer to the final consumer is inimical to the efficacy of pharmaceutical products and is the primary cause of Substandard and Falsified (SF) […]
Urgent Call to Action: Manufacturers and Importers Urged to Cease Supplying Medicines in Open Market in Kano
Please recall the last judgement delivered by the court of appeal ordering kano medicine dealers to vacate Niger street/Sabon-gari market and to relocate to the coordinated wholesale centre at dangwauro, Kano. NAFDAC and PCN hereby warn manufacturers, importers, company representatives, and all distributors to from this very moment cease supplying, pharmaceuticals, medical devices, and other […]
